November 27, 2013 (NOT-OD-14-027) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after January 25, 2014. Forms-C applications are required for due dates on or after January 25, 2014.

August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.

The purpose of the NIDCD Research Career Enhancement Award
for Established Investigators (K18) program is to enable established, proven
investigators to augment or redirect their research programs through the
acquisition of new research skills to answer questions relevant to the
hearing, balance, smell, taste, voice, speech and language sciences.

Key Dates

Posted Date

April 10, 2013

Open Date (Earliest Submission Date)

May 12, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard
dates apply, by 5:00 PM local time of applicant organization.

The
overall goal of the NIH Research Career Development program is to help ensure
that a diverse pool of highly trained scientists is available in appropriate scientific
disciplines to address the Nation's biomedical,
behavioral, and clinical research needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The objective of the NIDCD Research Career Enhancement Award
for Established Investigators (K18) program is to help ensure that a diverse
pool of highly trained, experienced scientists remains current in
state-of-the-art techniques, evolving technologies and fundamental,
translational and clinical research frontiers, and is available in appropriate
numbers to address the Nation's biomedical, behavioral and clinical research
needs in hearing, balance, smell, taste, voice, speech and language. This
intiative provides candidates with protected time and mentored guidance to
augment or redirect their research career trajectories within the NIDCD research
mission.

Established investigators often express an urgent need for
compensated protected time and mentored training to augment their research
capabilities and to keep their research programs in-step with emerging
technologies and evolving scientific frontiers and, thereby, competitive for
continued NIH funding. The Ruth L. Kirschstein National Research Service
Awards (NRSAs) for Individual Senior Fellows (F33) program provides one option
for fulfilling that need. This K18 initiative provides an alternative and
potentially more flexible approach.

This FOA focuses on established investigators holding the
academic rank of Associate Professor or Professor, or the equivalent in
non-academic research settings, who have records of scientific accomplishment and
independent research support (past and/or present). Its purpose is to provide
such investigators with support for short-term, intensive periods of mentored
research experience over a period of six- to twenty-four months to acquire new
research capabilities in the study of hearing, balance, smell, taste, voice,
speech and language. Such experiences, typically undertaken during an academic
sabbatical year, will afford candidate investigators protected time to: 1)
enrich and expand their expertise and research programs through retooling in
new techniques, emerging technologies, and/or scientific areas; 2) redirect
their research programs in new trajectories within the NIDCD scientific
mission; and/or, 3) catalyze research collaborations in new research directions.
It is expected that this initiative will lead to new and augmented research
programs competitive for NIH funding. In addition to serving as a short-term
career development vehicle for investigators within the NIDCD Extramural
research community, this program is also intended for investigators working
outside of the hearing, balance, smell, taste, voice, speech, and language
sciences who wish to add trajectories within the NIDCD scientific mission to
their overall research programs.

The research career enhancement experience shall take place
in a host laboratory, whether in the candidate's home institution (i.e., in
which the candidate holds his/her primary appointment) or in another
institution with the appropriate resources to provide the proposed research
career development experience. In both cases, the tutelage of a well-qualified
sponsor/mentor (or team of mentors/sponsors) is required. In most cases, the
applicant and proposed mentor(s) and host laboratory will not have had previous
research collaborations. The sponsoring institution (i.e., the institution of
the host laboratory for the K18 experience) must demonstrate a commitment to
provide the environment, research resources and protected time needed by the
candidate to perform the activities included in the research and career
development plans. Similarly, the candidate's Department Chair (at the home
institution) must provide a letter confirming that the candidate will be
provided the requisite protected time to pursue the proposed research
enhancement experience.

The research career development experience proposed must
have the potential to substantially augment the research capabilities of the
candidate at his/her home institution, and provide new research opportunities
and benefits that would not be achievable through a collaborative research
grant with the mentor(s). The research career enhancement experience should be
tailored to the individual needs and level of experience of the candidate, and
will generally incorporate two components: 1) didactic (e.g., directed
study/tutorials, semester-long courses, short courses, seminar series, journal
clubs) and/or laboratory-based training/instruction in the new discipline,
techniques or technologies; and, 2) a small-scale research project in the host
laboratory. The laboratory experience may comprise fundamental, translational
or clinical/patient-oriented research (including epidemiologic, outcomes and
health services research.

The candidate is required to devote at least half-time (50%)
effort to the program, allowing for a meaningful research career development
experience, over a period of six months to two years. The allowance for a
part-time commitment of professional effort will enable candidates to hold
their ongoing research grants (if applicable) and meet their academic
responsibilities in a limited capacity, and in accordance with NIH policy, as
they pursue the career enhancement program.

Special Note: Prospective applicants are strongly
encouraged to consult with NIDCD staff well in advance of applying for this
award to ensure that their applications meet the Institute's programmatic
requirements.

Section II. Award
Information

Funding Instrument

Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.

Application
Types Allowed

New
Resubmission

The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The actual number of awards is contingent upon NIH
appropriations and the submission of a sufficient number of meritorious
applications.

NIDCD anticipates funding 3-5 awards, corresponding to a
projected total of $600,000 per year.

Award Budget

Award budgets are composed of salary and other
program-related expenses, as described below.

Award Project Period

Generally, the research experience shall span a contiguous
period of six months to two years.

Other Award Budget
Information

Salary

NIDCD will contribute up to the legislatively mandated salary cap in effect at the time of award per year toward the salary of the career award recipient. The total salary provided by the award will be prorated based on a full-time, 12-month staff appointment and
the support period requested.

K18 award recipients may hold independent research
support, either Federal or private, concurrently with this award, and may
derive additional compensation for effort from other Federal sources or
awards. However, the total salary derived from all Federal sources may not
exceed the legislatively mandated salary cap, and the total percentage effort
cannot exceed 100%.

The total salary requested must be based on a full-time staff appointment. The
salary must be consistent both with the established salary structure at the
institution and with salaries actually provided by the institution from its
own funds to other staff members of equivalent qualifications, rank, and responsibilities
in the department concerned.

The sponsoring institution may supplement the NIDCD salary contribution up to
a level that is consistent with the institution's salary scale. However,
supplementation may not be from Federal funds unless specifically authorized
by the Federal program from which such funds are derived. In no case may PHS
funds be used for salary supplementation. Institutional supplementation of
salary must not require extra duties or responsibilities that would interfere
with the purpose of the career award.

Other Program-Related Expenses

NIDCD will contribute $40,000 per year toward the research development costs of the award recipient, which must be justified and
consistent with the stage of development of the candidate and the proportion
of time to be spent in research or career development activities.

Salary for mentors, secretarial and administrative assistants, etc. is not
allowed.

Indirect Costs

Indirect Costs (also known as Facilities &
Administrative [F&A] Costs) are reimbursed at 8% of modified total direct
costs.

NIH grant policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Applicant organizations must complete the following registrations
as described in the SF424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

System for
Award Management (SAM)– must maintain an active entity registration
(formerly CCR registration), to be renewed at least annually. Use the Sam.gov
“Manage Entity” function to manage your entity registrations. See the Grants
Registration User Guide at SAM.gov for additional information.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due
date. Applicant organizations are strongly encouraged to start the registration
process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal
Investigator)

Any candidate with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her mentor and organization to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support. Multiple PDs/PIs are
not allowed.

By the time of award, the individual must be a citizen or a
non-citizen national of the United States or have been lawfully admitted for
permanent residence (i.e., possess a currently valid Permanent Resident Card
USCIS Form I-551, or other legal verification of such status).

Candidates for this award must have a research or
health-professional doctoral degree, or a combined health-professional and
research doctoral degree. This award is intended for well-established
investigators at the academic rank of Associate Professor or Professor, or the
equivalent in non-academic settings, who have established records of
independent, peer-reviewed Federal or private research grant funding.
Applicants are not required to have active research grant support at the time
of application for this award.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Candidates may submit research project grant (RPG) applications
concurrently with their K18 application. However, applicants for this program
may not concurrently apply for any other PHS award that duplicates the
provisions of this FOA.

Individuals are eligible to apply for this FOA if they have
been or are currently a PD/PI on an NIH research grant (such as R01, R29, P01)
or a subproject leader on a Program Project (P01) or Center Grant (P50), or a
non-NIH equivalent to these grants/awards. K18 award recipients may hold
independent research support, either Federal or private, concurrently with this
award and may derive additional compensation for effort from other Federal
sources or awards. However, the total salary derived from all Federal sources
may not exceed the maximum legislated salary rate and the total percentage
effort cannot exceed 100%.

The candidate is required to devote at least 6 calendar
months (50% of full-time professional effort) to the K18 program, but may
devote their full-time (12 calendar months) effort to it. For information
regarding NIH policy on determining full-time professional effort for career
awards, see NOT-OD-04-056.
The allowance for a part-time commitment of professional effort will enable
candidates to hold their ongoing research grants (if applicable) and/or meet
their academic responsibilities in a limited capacity, and in accordance with
NIH policy, as they pursue the career enhancement program. However, the total
effort cannot exceed 100%, and all other activities must be consistent with the
goals of the K18 award. Applicants should describe any clinical,
administrative, teaching, mentoring or grant-related research commitments they
intend to maintain during the period of the award, and the arrangements to be
made with the home institution and/or the sponsoring institution to ensure the
requisite protected time for this award period. Generally, the research
experience shall span a contiguous period of six months to two years. However,
a six-month research experience may be apportioned over two successive summer
semesters (of three months each), provided the experience is pursued on a
full-time (100%) basis during these periods.

Level of Effort

At the time of award, the candidate must have a “full-time”
appointment at the academic institution that is the applicant institution. Candidates
who have VA appointments may not consider part of the VA effort toward
satisfying the “full time” requirement at the applicant institution. Candidates
with VA appointments should contact the staff person in the relevant Institute
or Center prior to preparing an application to discuss their eligibility. Under
certain circumstances, an awardee may submit a written request to the awarding
component requesting a reduction in minimum required percent effort, which will
be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.

Mentor(s)

Before submitting the application, the candidate must identify
a mentor who will guide the proposed career development and research
experience. The mentor should be an active investigator in the area of the
proposed research and be committed both to the career development of the
candidate and to the direct supervision of the candidate’s research. The mentor
must document the availability of sufficient research support and facilities
for high-quality research. The mentor, or a member of the mentoring team,
should have a successful track record of mentoring. Candidates are encouraged
to identify more than one mentor, i.e., a mentoring team, if this is deemed
advantageous for providing expert advice in all aspects of the research career
development program. In such cases, one individual must be identified as the
primary mentor who will coordinate the candidate’s research. The candidate must
work with the mentor(s) in preparing the application.

The mentor should describe the career development plan for the candidate
(coordinated with the candidate’s research strategy). The description of the
career development plan should include items such as classes, seminars,
directed study arrangements, and opportunities for interaction with other
groups and scientists. The research environment and the availability and
quality of needed research facilities and research resources (e.g., equipment,
laboratory space, computer time, available research support, etc.) must also be
described.

Section IV. Application
and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for review.

All page limitations described in the SF424 (R&R)
Application Guide and the Table of
Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all
applicable components, required and optional. Please note that some components marked optional in the application package are required
for submission of applications for this FOA. Follow the instructions in the
SF424 (R&R) Application Guide to ensure you complete all appropriate
“optional” components.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide, including
Supplemental Instructions to the SF424 (R&R) for Preparing an Individual
Research Career Development Award (CDA) Application (“K” Series), must be
followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide, including
Supplemental Instructions to the SF424 (R&R) for Preparing an Individual
Research Career Development Award (CDA) Application (“K” Series), must be
followed.

Other Project Information

All instructions in the SF424 (R&R) Application Guide, including
Supplemental Instructions to the SF424 (R&R) for Preparing an Individual
Research Career Development Award (CDA) Application (“K” Series), must be
followed.

SF424(R&R) Senior/Key Person Profile Expanded

All instructions in the SF424 (R&R) Application Guide, including
Supplemental Instructions to the SF424 (R&R) for Preparing an Individual
Research Career Development Award (CDA) Application (“K” Series), must be
followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide, including
Supplemental Instructions to the SF424 (R&R) for Preparing an Individual
Research Career Development Award (CDA) Application (“K” Series), must be
followed.

PHS 398 Cover Letter

All instructions in the SF424 (R&R) Application Guide, including
Supplemental Instructions to the SF424 (R&R) for Preparing an Individual
Research Career Development Award (CDA) Application (“K” Series), must be
followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide, including
Supplemental Instructions to the SF424 (R&R) for Preparing an Individual
Research Career Development Award (CDA) Application (“K” Series), must be
followed.

PHS 398 Checklist

All instructions in the SF424 (R&R) Application Guide, including
Supplemental Instructions to the SF424 (R&R) for Preparing an Individual
Research Career Development Award (CDA) Application (“K” Series), must be
followed.

PHS 398 Career Development Award Supplemental Form

All instructions in the SF424 (R&R) Application Guide, including
Supplemental Instructions to the SF424 (R&R) for Preparing an Individual
Research Career Development Award (CDA) Application (“K” Series), must be
followed, with the following additional instructions:

Candidate Information

All instructions in the SF424 (R&R) Application
Guide must be followed, with the following additional instructions:

Candidate’s
Background

Describe the candidate's commitment to a health related research
scientist career in the hearing, balance, smell, taste, voice, speech or
language sciences.

Describe the candidate's research efforts and accomplishments in
health related research to date as an independent investigator, including
publications, prior research interests and experience, and history of research
support.

Present evidence of the candidate's potential to augment his/her
research career and to ultimately advance scientific progress through this
career enhancement plan.

Present evidence of the candidate’s ability to interact and
collaborate with other scientists.

Career
Goals and Objectives

Describe the candidate's future career goals and objectives and
research career trajectory to date, and how these relate to the proposed
research career development enhancement program.

Justify the need for further career enhancement in order to
achieve the candidate's future research goals.

Demonstrate how the proposed career enhancement program and the
research, educational and mentoring resources of the sponsoring laboratory and
institution will further the stated research career goals.

Career
Development/Training Activities During Award Period

The candidate and the mentor are jointly responsible for the
preparation of the career development plan. The candidate and mentor may
propose a mentoring team (and/or an advisory committee).

Describe the career development plan, tailoring it to the
candidate's goals, prior experience and career level, as well as to the intent
of the K18 initiative.

Provide a systematic plan for progression of career enhancement
and research experiences for the period of the award and beyond, including a
timeline for the phasing of the career enhancement and research activities.

Explain how the career development plan will help launch the
candidate in an augmented independent research career trajectory.

Training
in the Responsible Conduct of Research

All instructions in the SF424 (R&R) Application
Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing
an Individual Research Career Development Award (CDA) Application (“K” Series),
must be followed.

Statements of Support

All instructions in the SF424 (R&R) Application
Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing
an Individual Research Career Development Award (CDA) Application (“K” Series),
must be followed, with the following additional instructions:

Statements
by Mentor, Co-mentor(s), Consultants, Contributors

The candidate must name a primary mentor (sponsor), who, together
with the candidate, is responsible for the planning, direction, and execution
of the program. The candidate may also identify co-mentors (i.e., secondary and
tertiary mentors), as appropriate to the goals of the program.

The mentor(s) should be recognized as an accomplished
investigator in the proposed research area and have a track record of success
in training scientists.

The mentor(s) should have sufficient independent research support
and laboratory resources to support the proposed research project, in excess of
the allowable costs of this award.

Each mentor and co-mentor(s) must provide a statement of his/her
areas of expertise and responsibility. Co-mentors should clearly describe how
they will contribute to the research mentoring
of the candidate. If any of the co-mentors is not located at the sponsoring
institution, a statement should be provided describing the mechanism(s) and
frequency of communication with the candidate, including the frequency of
personal meetings.

Signed statements must be provided by all consultants/collaborators
confirming their participation in the project and describing their specific
roles. Collaborators and consultants generally do not need to provide their
biographical sketches. However, information should be provided clearly
documenting the appropriate expertise in the proposed areas of
consulting/collaboration. Collaborators/consultants are generally not directly
involved in the career development of the candidate. Any other opportunities
for the candidate's professional growth should also be documented in these
statements.

The application must include a statement from the primary mentor
providing: (1) information on his/her research qualifications and previous
experience as a research supervisor; (2) a plan that describes the nature of
the supervision and mentoring that will occur during the proposed award period,
including how the candidate’s scientific and professional independence will be
promoted; and, (3) a description of the elements of the planned research career
development plan, including any didactic and hands-on laboratory training
components.

The primary mentor must agree to provide annual evaluations of
the candidate’s progress as required in the annual progress report.

Environmental and Institutional Commitment to the
Candidate

All instructions in the SF424 (R&R) Application
Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing
an Individual Research Career Development Award (CDA) Application (“K” Series),
must be followed, with the following additional instructions:

Description
of Institutional Environment

The sponsoring institution must document a strong, well-established
research program with key faculty members that is well-suited for the
candidate's proposed research enhancement program.

Describe and provide assurance of the research facilities,
resources and training opportunities within the host laboratory/laboratories
and the sponsoring institution that will be available to the candidate.

Institutional
Commitment to the Candidate’s Research Career Development

The sponsoring institution must provide a statement of commitment
to the candidate's research career enhancement, and to meeting the requirements
of this award. The sponsoring institution must provide the candidate with the
appropriate facilities and other resources to carry out the proposed Research
Plan.

Provide assurances that appropriate time and support for any
proposed mentor(s) and/or other staff consistent with the career development
plan will be provided.

The candidate's home institution must provide a clear and
unambiguous statement of assurance that during the period of the K18 award the
candidate will be released from all duties that infringe on his/her commitment
of effort to the award. The institutional statement should also indicate what
duties, if any, the candidate will continue to perform during the award.

Research Plan

All instructions in the SF424 (R&R) Application
Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing
an Individual Research Career Development Award (CDA) Application (“K” Series),
must be followed, with the following additional instructions:

Research
Strategy

A sound research project that is consistent with the candidate’s
level of research development and objectives of his/her career development plan
must be provided. The research description should demonstrate not only the
quality of the candidate’s research thus far but also the novelty,
significance, creativity and approach, as well as the ability of the candidate
to carry out the proposed research.

The application must also describe the relationship between the
mentor’s research program and the candidate’s proposed research plan, and
demonstrate the feasibility of conducting this research in the host
laboratory/laboratories. If more than one mentor is proposed, the respective
areas of expertise and responsibility should be described.

Currently supported research: There is no need to provide
extensive detail with regard to ongoing, funded research in the host laboratory.
Enough information should, however, be provided to permit the peer reviewers to
evaluate the extent, special features and general quality of the candidate's
research activities and mentored research training.

Appendix

Do not use the Appendix to circumvent page limits.
Follow all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

Letters of Reference

Candidates must carefully follow the SF424 (R&R)
Application Guide, including the time period for when letters of reference
will be accepted (letters are due by the application due date as described
in the Notice).
Applications lacking the appropriate required reference letters will not be
reviewed. This is a separate process from submitting an application
electronically. Reference letters are submitted directly through the eRA Commons
Submit Referee Information link and not through Grants.gov.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants are
responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are
provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for
more information on the electronic submission process, visit Applying
Electronically.

Important reminders:All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile Component of the SF424(R&R)
Application Package. Failure to register in the Commons and to include a
valid PD/PI Commons ID in the credential field will prevent the successful
submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Applications that are
incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers should provide their assessment of the likelihood
for the candidate to maintain a strong research program, taking into
consideration the criteria below in determining the overall impact score.

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact.

Candidate

Has the candidate provided evidence of excellence as
an independent investigator, including his/her record of research support and
publication output?
Does the candidate show evidence of a high level of commitment to meeting the
program's career enhancement objectives?
Does the candidate have high potential for successfully augmenting his/her
research career capabilities and in becoming an outstanding contributor to the
research field relevant to the proposed research enhancement experience?

Career Development Plan/ Career Goals
& Objectives/ Plan to Provide Mentoring

Is the career development plan appropriate in its
content, scope, duration, and phasing for the candidate's stated career
development goals?
Is there a high likelihood that the proposed program will contribute
substantially to the advanced research career enhancement of the candidate?

Is an appropriate level of the candidate's
professional effort to the career development plan documented in the
application?

Research Plan

Is the proposed research project appropriate for the
candidate's stage of research development and as a vehicle for developing the
research skills described in the career development plan?
Is the research plan, including the research question, specific aims, design
and methods, of high scientific and technical merit?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

Are the mentor(s) research qualifications, scientific
stature, experience, and mentoring track record appropriate for the candidate's
research career development needs?
Does the mentor(s) adequately address the above review criteria in his/her
statement?
Are the nature and extent of mentorship proposed adequate and appropriate, and
is the commitment of the mentor(s) to the candidate's advanced research career
development appropriate?
Does the mentor(s) have a history of research productivity and support, and a
prior track record in research mentoring?

Environment & Institutional
Commitment to the Candidate

Are appropriate and high-quality research resources
and training opportunities available to the candidate at the sponsoring
institution?
Is there clear commitment from both the candidate's home institution and
sponsoring institution to ensure that the requisite effort of the candidate
will be devoted directly to the research career enhancement activities
described in the application?
Is there strong institutional commitment to fostering the advanced research
career development of the candidate?
Are there unique features of the scientific environment of the sponsoring
institution and host laboratory that will benefit the proposed research and
career development plan (e.g., useful collaborative arrangements, special
equipment or analytic methods, unique subject populations)?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and technical
merit, and in providing an overall impact score, but will not give separate
scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: (1) risk to
subjects, (2) adequacy of protection against risks, (3) potential benefits to
the subjects and others, (4) importance of the knowledge to be gained, and (5)
data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate: (1) the justification for the exemption, (2) human
subjects involvement and characteristics, and (3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: (1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; (2) justifications for the use of animals
and for the appropriateness of the species and numbers proposed; (3) adequacy
of veterinary care; (4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and (5) methods of euthanasia and
reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet for
Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application now presented, taking into consideration the responses to critiques
and comments from the previous scientific review group and changes made to the
project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Training in the Responsible Conduct
of Research

Taking into account the circumstances of the candidate, including the more senior level of experience of
candidates for this award, the reviewers will evaluate plans for instruction in
responsible conduct of research (RCR), as well as past record of instruction in
RCR, as appropriate. Reviewers will specifically address the Format, Subject
Matter, and Frequency of instruction, as detailed in NOT-OD-10-019. Plans and past record will be rated as acceptable or unacceptable, and the
summary statement will provide the consensus of the review committee.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including (1) the Select Agent(s) to be used
in the proposed research, (2) the registration status of all entities where
Select Agent(s) will be used, (3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and (4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the NIDCD. Applications will compete for available funds
with all other recommended applications . Following initial peer review, recommended applications will receive a second level of
review by the National Deafness and Other Communication Disorders Advisory
Council. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

A final progress report, invention statement, and the
expenditure data portion of the Federal Financial Report are required for
closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

4. Evaluation

In carrying out its stewardship of human resource-related
programs, the NIH may request information essential to an assessment of the
effectiveness of this program from databases and from participants themselves. Participants
may be contacted after the completion of this award for periodic updates on
various aspects of their employment history, publications, support from
research grants or contracts, honors and awards, professional activities, and
other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

It is particularly important to consult with the NIDCD Scientific/Research
Contact well in advance of the planned application date to ensure that the
research to be proposed in the application is within the NIDCD research mission
and that the planned career development plan is consistent with the FOA
programmatic requirements.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.